Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04709575
• Other study ID #: R5713-5714-5715-ALG-2001
• Secondary ID: 2020-004094-52
• Status: Completed
• Phase: Phase 3
• Start date: January 14, 2021
• Est. completion date: August 24, 2021

Study information

• Verified date: September 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: August 24, 2021
• Est. primary completion date: August 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

1. Documented or participant-reported history of birch pollen-triggered allergic rhinitis symptoms, with or without conjunctivitis, for at least 2 years

2. Positive Skin prick test (SPT) with birch pollen extract in the screening period, as defined in the protocol

3. Positive Allergen-specific IgE (sIgE) tests for birch pollen and Bet v 1 in the screening period, as defined in the protocol

4. Willing and able to comply with clinic visits and study-related procedures

Key Exclusion Criteria:

1. Participation in a prior REGN5713-5714-5715 clinical trial

2. Recurrent or chronic rhinitis or sinusitis not associated with birch pollen season, or due to daily contact with other allergens causing symptoms that are expected to coincide with birch pollen season, as assessed by the investigator

3. Participants who anticipate major changes in allergen exposure in their home or work environments that are expected to coincide with the study assessments as assessed by the investigator

4. Persistent chronic or recurring acute infection requiring treatment with antibiotics, antivirals, or antifungals, or any untreated respiratory infections (at the discretion of the investigator) within 4 weeks prior to screening visit. Participants may be re-evaluated for eligibility after symptoms resolve

5. Documentation of active SARS-CoV-2 infection, as defined in the protocol

6. A clinical history of asthma with 2 or more asthma exacerbations requiring hospitalizations or systemic corticosteroids in the previous year

7. History of birch allergy immunotherapy as defined in the protocol

8. Use of anti-IgE or other biological therapy in treatment of asthma or allergy within 6 months prior to screening

NOTE: Other protocol defined Inclusion/Exclusion Criteria apply

Related Conditions & MeSH terms

• Allergic Rhinitis
• Conjunctivitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• REGN5713
Administered subcutaneously
• REGN5714
Administered subcutaneously
• REGN5715
Administered subcutaneously
• Placebo
Placebo that replaces REGN5713-5714-5715

Locations

Country	Name	City	State
Belgium	Regeneron Study Site	Gent	Oost-Vlaanderen
Belgium	Regeneron Study Site	Leuven	Vlaams Brabant
Canada	Regeneron Study Site	Kingston	Ontario
Canada	Regeneron Study Site	London	Ontario
Canada	Regeneron Study Site	Ottawa	Ontario
Canada	Regeneron Study Site	Quebec
Canada	Regeneron Study Site	Toronto	Ontario
Canada	Regeneron Study Site	Toronto	Ontario
Canada	Regeneron Study Site	Toronto	Ontario
Canada	Regeneron Study Site	Trois-Rivieres	Quebec
Denmark	Regeneron Study Site	Hellerup	Copenhagen Surroundings
Denmark	Regeneron Study Site	Hvidovre	Capital
Denmark	Regeneron Study Site	Vejle	South Jutland
Germany	Regeneron Study Site	Berlin
Germany	Regeneron Study Site	Berlin
Germany	Regeneron Study Site	Dreieich	Hessen
Germany	Regeneron Study Site	Dresden	Sachsen
Germany	Regeneron Study Site	Duisburg	Nordrhein-Westfalen
Germany	Regeneron Study Site	Dusseldorf	North Rhine-Westphalia
Germany	Regeneron Study Site	Hamburg
Germany	Regeneron Study Site	Heidelberg	Baden-Wurttemberg
Germany	Regeneron Study Site	Stuttgart	Baden-Wurttemberg
Germany	Regeneron Study Site	Wiesbaden	Hessen
United States	Regeneron Study Site	Baltimore	Maryland
United States	Regeneron Study Site	Bangor	Maine
United States	Regeneron Study Site	Cincinnati	Ohio
United States	Regeneron Study Site	Columbia	Missouri
United States	Regeneron Study Site	Great Neck	New York
United States	Regeneron Study Site	Greenfield	Wisconsin
United States	Regeneron Study Site	Lincoln	Rhode Island
United States	Regeneron Study Site	Missoula	Montana
United States	Regeneron Study Site	Pittsburgh	Pennsylvania
United States	Regeneron Study Site	Plymouth	Minnesota
United States	Regeneron Study Site	Portland	Oregon
United States	Regeneron Study Site	Saint Louis	Missouri
United States	Regeneron Study Site	Toledo	Ohio
United States	Regeneron Study Site	Verona	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Denmark,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined Symptom and Medication Score (CSMS) in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).	Until the end of Birch Pollen Season, up to Week 16
Secondary	Total Symptom Score (TSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)	Until the end of Birch Pollen Season, up to Week 16
Secondary	Total Nasal Symptom Score (TNSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.	Until the end of Birch Pollen Season, up to Week 16
Secondary	Total Ocular Symptom Score (TOSS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)	Until the end of Birch Pollen Season, up to Week 16
Secondary	Daily Medication Score (DMS), Averaged Over the Duration of the Birch Pollen Season, in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)	Until the end of Birch Pollen Season, up to Week 16
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Throughout the Study	Number of participants with any Treatment Emergent Adverse Events (TEAEs) from participating in study	Up to Day 127
Secondary	Number of Participants With Serious TEAEs Throughout the Study	Number of participants with any Serious Treatment Emergent Adverse Events (TEAEs) from participating in study	Up to Day 127
Secondary	Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo	Number of participants who showed change from baseline to the end of the study in Birch Skin Prick Test (SPT) Mean Wheal Diameter, in participants who received REGN5713-5714-5715 compared to placebo	Baseline through Day 127
Secondary	Percent Change From Baseline to the End of Study in Birch SPT Mean Wheal Diameter in Participants Who Receive a Single Dose of REGN5713-5714-5715 Versus Placebo		Baseline through Day 127
Secondary	Serum Concentration of REGN5713 Over the Study Duration		Day 0, Day 56, Day 112
Secondary	Serum Concentration of REGN5714 Over the Study Duration		Up to Day 127
Secondary	Serum Concentration of REGN5715 Over the Study Duration		Up to Day 127
Secondary	Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5713 Throughout the Study	Percentage of participants who developed antibodies to intervention provided during study	Up to Day 127
Secondary	Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5714 Throughout the Study	Percentage of participants who developed antibodies to intervention provided during study	Up to Day 127
Secondary	Percentage of Participants With Treatment Emergent Anti-drug Antibodies to REGN5715 Throughout the Study	Percentage of participants who developed antibodies to intervention provided during study	Up to Day 127
Secondary	Number of "Well Days"	"Well Days" are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is =2/18	Until the end of Birch Pollen Season, up to Week 16